Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study Investigating the Effect of ALN-4324 on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
Led by Alnylam Pharmaceuticals · Updated on 2026-05-14
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a single dose of ALN-4324 on whole-body insulin sensitivity in adults with Type 2 Diabetes Mellitus (T2DM). This phase 2, randomized, double-blind, placebo-controlled trial aims to assess how well ALN-4324 works compared to a placebo in improving insulin sensitivity, which is important for managing blood sugar in T2DM patients. Participants will receive either one subcutaneous injection of ALN-4324 or a matching placebo. The study is designed with two groups, and each participant only receives a single dose. The trial includes a follow-up period lasting up to 9 months to monitor effects and safety. During the study, participants will be evaluated through various assessments including changes in insulin sensitivity measured by the M-value and M/I ratio, endogenous glucose production, and Hemoglobin A1c levels. Researchers will also track the frequency of adverse events for safety. These measurements will be taken from baseline and followed for up to 6 months, with some safety monitoring extending to 9 months after dosing.
CONDITIONS
Brief Title
A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with a confirmed diagnosis of Type 2 Diabetes Mellitus
- Body mass index (BMI) of 25 kg/m² or higher and less than 39.9 kg/m²
- Hemoglobin A1c (HbA1c) between 6.5% and less than 10.5%
- On a stable dose of metformin
You will not qualify if you...
- Any clinically significant disease, medical condition, or abnormal lab result that could affect safety or study results
- Receiving treatments that interfere with glucose or insulin metabolism other than current Type 2 Diabetes treatment or birth control methods
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive a single subcutaneous dose of ALN-4324 or placebo to evaluate its effect on insulin sensitivity.
1 baseline visit and multiple follow-up visits up to Month 6
Duration - Up to 3 additional months after treatment
Participants are monitored for safety and adverse events following treatment.
Periodic visits up to Month 9
Trial Site Locations
Total: 1 location
1
Clinical Trial Site
Chula Vista, California, United States, 91911
Actively Recruiting
Research Team
A
Alnylam Clinical Trial Information Line
A
Alnylam Clinical Trial Information Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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